HLC's will typically be summoned when local elders become aware of congregation members who are running into difficutly obtaining non-blood alternative therapy.
And how handy it is when there are clinical trials that are designed specifically with Jehovah's Witnesses in mind.
The JWs make for an ideal trial group - not only do they not smoke, but it is relatively easy to recruit to clinical trials when you have an entire Watchtower Society department behind your recruiting process. Which involves big money, by the way - drug companies pay well for trial recruiting.
This is a clinical trial that was approved in August 2010.
https://clinicaltrials.gov/ct2/show/NCT01183988?term=jehovah%27s+witnesses&rank=1
The group that is primarily targeted in the above drug trial is pregnant Jehovah's Witness women whose babies would normally require an exchange transfusion.
The purpose of this protocol is to make Stanate® (Stannsoporfin, tin-mesoporphyin) available to infants who meet the following criteria: 1) the infant has a very high level of bilirubin without an adequate clinical response to phototherapy 2)requires exchange transfusion and 3) the family refuses to allow the administration of blood products, particularly on religious grounds, such as the Jehovah's Witness Community.
The study was initially "by invitation only".
ENROLLING BY INVITATION - A clinical study that selects its participants from a population, or group of people, decided on in advance by the researchers. These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate.
In May 2014, Infacare, the pharmaceutical company that produces Stanate, applied for and got approval to change the clinical trial to 'Expanded Access" and the trial has been extended to 2017.
https://clinicaltrials.gov/ct2/show/NCT00076960?term=jehovah%27s+witnesses&rank=2
Expanded access:
http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm
Expanded access, also called “compassionate use” is a regulation that makes promising drugs and devices available to patients with serious or immediately life-threatening diseases.
Just as in clinical trials, these investigational drugs/devices have not yet been approved by the FDA and they have not been proven to be safe and effective.
They may be effective in the treatment of a condition, or they may not. It is important to remember that the drug/device may have unexpected serious side effects and that patients need to consider all the possible risks when seeking access to an investigational drug or device.
Did those JW women who listened to the HLC, concerning their maternity care, know that they were/are part of a clinical trial? How informed, really, was their consent in accepting Stanate as an alternative treatment for their babies? Or did they just let the HLC exercise their 'power of attorney' in making the decision to enroll them and their babies in a clinical trial?
Do the JWs who let the HLC make their medical decisions really know what they are receiving for alternative treatment when they refuse allogenic blood transfusions? Do they realize that the HLC are actually acting in the capacity of recruiters for clinical trials and medical studies?
And yet another example of JWs being used for drug trials (this study was published in 1990):
http://journals.lww.com/ccmjournal/Abstract/1990/11000/Fluosol_DA_20_in_the_treatment_of_severe_anemia_.8.aspx
Abstract
We evaluated the safety and efficacy of Fluosol DA-20% (FDA) as a blood substitute in the treatment of severe anemia. Thirty-six patients received either FDA (n = 21) or crystalloid/hydroxyethyl starch (CHS) (n = 15) as part of a randomized, controlled trial. Ten pa-' tients received FDA as part of a humanitarian protocol. All were Jehovah's Witnesses who refused transfusion, had bled recently, and had average Hgb levels of 4.3 g/ dl
Out of the 36 patients, a total of nineteen died.
Nineteen patients died: 12 (37.5%) FDA, seven (46.6%) control.
The conclusions of the researchers:
In this study, inability of FDA to sustain increased oxygen content was due in part to the rapid elimination of FDA and also to the limited amount given. Repeat infusions of FDA to maintain a steady fluorocrit could lead to sustained oxygen content increases and improved survival. Further studies of FDA seem warranted.
Cool...the researchers shouldn't have too much trouble finding subjects for "further studies".
All they will have to do is drop a line to the Watchtower Society and the Hospital Liasion guys can set that right up for them.
How many JWs have had experimental procedures and/or drugs given to them without knowing that they were being entered into a clinical trial or medical study?
